Evaluation of a Personcentered Internet-based CBT Program for Stress, Anxiety and Depressive Symptoms in Patients With Cardiovascular Disease
NCT ID: NCT04726722
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
215 participants
INTERVENTIONAL
2023-03-13
2025-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Internet-guided Cognitive Behavioural Therapy to Improve Depression Patients With Cardiovascular Disease
NCT02778074
Internet Cognitive Behavioural Therapy to Patients With Heart Failure and Depression
NCT01681771
Internet-based Cognitive Behavior Therapy After Myocardial Infarction
NCT01504191
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
NCT01591720
Internet-based Cognitive Behavioural Therapy for Cardiac Patients
NCT04053244
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse.
Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses.
Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Design of the CBT treatment content
Patient determined CBT content (i.e. person-centered) vs. therapist determined I-CBT content
internet-based cognitive behavioral theraphy
When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules.
Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired
Control of support and feedback
Patient-controlled support and feedback (person-centred) vs. therapist -controlled.
internet-based cognitive behavioral theraphy
When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules.
Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
internet-based cognitive behavioral theraphy
When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules.
Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines
* stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks.
* stress (Perceived Stress Scale (PSS)-10\>13 points) and/or
* anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or
* depressive symptoms (Patient Health Questionnaire-9 28 (PHQ-9) \> 5 points)
Exclusion Criteria
* severe stress, anxiety or depression assessed as requiring acute treatment
* not being able to dedicate 3-4 hours per week to participate in the program
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Linkoeping
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Peter Johansson
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Peter Johansson, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Department of Health, Medicine and Caring Sciences, Linkoping University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Peter Johansson
Norrköping, Linköpings Universitet, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-00935
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.